A Phase 2/3 interventional study of Cognitive-behavioral therapy and Treatment as Usual in Autism, Asperger's Syndrome and Generalized Anxiety Disorder, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-02.
Sponsored by University of South Florida · Phase 2/3, Interventional, and Treatment
Among 601 studies in Autistic Disorder with a site in United States — 121 open to participants now, 150 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 601 studies in Autistic Disorder with a site in United States, this one is the 244th largest by enrollment of the 503 interventional ones that give a count, is one of 26 that started in 2010, is one of 14 in phase 2/3, and was the 139th registered.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
Browse Autistic Disorder studies →121 of the 601 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Stony Brook University · Sites in United States
Christopher John McDougle, M.D. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 181 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 141 (78%) stop at 75 or younger; 146 take children under 18; 56 take healthy volunteers.
This study: 7 Years to 11 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
601 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 26 started in 2010.
This study's enrollment of 45 is close to the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Median enrollment 44 across the 503 interventional studies, 131 across the 95 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
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73 of 601 have an industry lead sponsor. The 10 most frequent:
University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
University of South Florida has 6 studies filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Among the 601 studies in Autistic Disorder with a site in United States, from their registry updates:
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Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning. Co-occurring conditions, such as anxiety, are common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Although effective interventions have been developed for typically developing youth with anxiety disorders, this approach needs to be adapted for children with autism. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with autism spectrum disorders and comorbid anxiety disorder(s).
Autism spectrum disorders affect as many as 1 out of 150 children (Centers for Disease Control, 2007), with many higher-functioning children not being diagnosed until elementary school or later (Fombonne, 2003). Significant impairment in social, adaptive, and school functioning is prevalent and longstanding (Howlin et al., 2004). In addition, comorbid psychological disorders are common in the ASD population (Simonoff et al., 2008), and may cause substantial distress and impairment beyond that caused by the ASD diagnosis. Comorbid anxiety disorders, in particular, affect as many as 80% of children and adolescents with ASD (Bellini, 2004; de Bruin et al., 2007; Klin et al., 2005; Muris et al., 1998). Although efficacious interventions have been developed for otherwise typically developing youth with anxiety disorders, the linguistic; cognitive; and social characteristics of ASD may render standard treatment approaches less effective for children with ASD (Volkmar \& Klin, 2000). Thus, there is a clinical need for the modification of existing treatment modalities for this unique group. To date, few studies have experimentally tested the efficacy of CBT for youth with a comorbid presentation of anxiety and ASD. This gap in the literature is of particular concern given the prevalence of comorbid anxiety among children, consequences of untreated anxiety, unknown efficacy of antidepressant medication for anxiety in ASD, and potential safety and tolerability issues related to medication use. Accordingly, we are proposing a randomized controlled trial to examine the efficacy of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with ASD and comorbid anxiety disorder(s). In the proposed grant, we will: (1) examine the acute efficacy of CBT relative to TAU, and (2) evaluate the short-term maintenance of treatment gains. Forty-six children (ages 7-11 years) with ASD and comorbid anxiety disorder(s) will be randomly assigned to one of the two treatment conditions. Primary outcomes will be assessed by an independent evaluator, and will include change in anxiety symptom severity; response rates; and remission rates. Considering the rising number of children diagnosed with ASD, our proposed work toward the advent of an efficacious CBT protocol will provide a timely contribution to public health efforts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
Behavioral: Cognitive-behavioral therapy
Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Behavioral: Treatment as Usual
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
Also known as: psychotherapy, counseling, therapy
Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)
This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.
Time frame: After an average of 16 weeks (Post-treatment)
Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)
This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.
Time frame: After an average of 16 weeks (Post-treatment)
Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).
This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.
Time frame: After an average of 16 weeks (Post-treatment)
Forty-five children between 7-11 years (M=8.89, SD=1.34) were recruited through referrals, advertisements, and the patient flow at a university-based mental health clinic. Recruitment took place between March, 2010 and ended around January, 2012.
| Milestone | Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|
| Started | 24 | 21 |
| Completed | 22 | 21 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.
| units on a scale | Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|
| Baseline | 16.33 ± 1.93 | 17.62 ± 2.04 |
| Post-treatment | 11.58 ± 3.15 | 16.05 ± 3.22 |
This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.
| units on a scale | Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|
| Baseline | 5.42 ± .72 | 5.62 ± .92 |
| Post-treatment | 3.38 ± 1.81 | 4.9 ± 1.51 |
This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.
| units on a scale | Cognitive-behavioral Therapy | Treatment as Usual |
|---|---|---|
| Baseline | 3.5 ± .72 | 4 ± .63 |
| Post-treatment | 2.67 ± .48 | 3.57 ± .87 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive-behavioral Therapy | — | 0/24 (0%) | 0/24 (0%) |
| Treatment as Usual | — | 0/21 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 24 | 21 | 45 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 8.83 ± 1.31 | 8.95 ± 1.40 | 8.89 ± 1.34 |
| Sex: Female, Male(Participants) | Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 19 | 17 | 36 |
| Region of Enrollment(participants) | Cognitive-behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| United States | 24 | 21 | 45 |
The record gives a start of Apr 2010, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2013, 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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